Ensuring effective quality management reviews – Five practices to adopt and avoid

In the past few years, the role of senior management in defining and establishing a quality management system (QMS) has been gaining importance.

While management responsibilities around QMS have been clearly defined by the ISO 9000 series of quality standards since the 1980’s, this concept was adopted much later by the regulated (pharmaceutical, life science, medical devices) industry. Periodic quality management reviews are one way in which the leadership team can fulfil this responsibility.

While most regulated industries conduct these reviews at least annually, they continue to struggle with sustained compliance, improvements, and cultural problems. In this article, I share my insights into common, ineffective quality management review practices and how utilising quality tools like eQMS can yield better outcomes.

Practice 1 – Avoid the “tick-box” approach.

Quality management reviews (QMR) often turn out to be a “tick-box” activity. Often, the reviews and the agenda items are not aligned with business goals.

While a discussion of the common QMS elements – deviations, CAPAs, change controls, training, risks etc. – does provide an insight into the health of the quality systems, it is also essential to review the agenda prior to every meeting and include other topics based on trends, customer responses, and employee feedback etc.

Additionally, the frequency of quality management reviews should also be revised based on current business needs and changes. For example, if an organisation has recently implemented a new manufacturing facility or line, you will need to increase the frequency of quality management reviews to assess the effectiveness of the implemented systems and the need for any changes.

Practice 2 – Address KPIs and non-compliances holistically

Key Performance Indicator (KPI) data and non-compliances are often reviewed in silos. Typically, action plans are created to address non-compliant KPIs, but these solutions may merely serve as quick fixes without addressing the underlying root causes.

The actions are considered the responsibility of the business function that has had the major non-compliance. For example, the most common KPI is around number of human error related deviations.

Most quality management reviews discuss this KPI and go a step further in identifying which department had the greatest number of such deviations. Actions are assigned to the department to address this. However, a more beneficial and effective approach would be to understand why the human errors are occurring irrespective of the function – could it relate to unclear SOPs, lack of training, inadequate resources, or incorrect location of equipment/documents? These are just some of the possible root causes to consider before you can move on to identifying appropriate, effective actions.

In addition, it is also important for the senior management team to discuss out-of-trend data regarding KPIs. In doing so, the team can identify potential issues and take necessary action to address them before they escalate into a compliance problem. Generating customisable reports through an eQMS tool is a good way to review relevant data.

Practice 3 – Improve communication and tracking

Quality management review discussions and outcomes often suffer from poor communication and tracking. In most organisations, the quality manager or head of quality generates a post-review report with a list of actions items. The report is circulated to different functional heads with the understanding that any actions identified for their function will be completed in the agreed upon time.

This process may work for very small organisations with few team members. However, problems arise when the organisation grows, more employees are brought on board, and the number of actions is large.

Actions often get left undone due to other competing priorities, only coming to light in the next quality management review meeting. Further, multiple individuals may be working in a silo to address the same action.

Utilising tools such as the task/action generation module of an eQMS, or automated workflows if they are available, can help break down communication silos and track actions. Actions are logged into the systems, responsible individuals assigned, and target dates set. This provides clarity for all involved and enables real-time tracking of action status by functional managers.

Practice 4 – Enhance employee awareness

The performance and effectiveness of implemented QMS – identified in quality management reviews as well as through everyday data – must be periodically and clearly communicated to employees to maintain sustained compliance.

Senior leadership holds the responsibility of effectively communicating the message and expectations around quality. Following quality management reviews, employees are informed of the outcome through an email with a lengthy report attached to it. While transparent, this approach can leave employees unable to gauge the system’s health or understand major issues.

A more effective method is to employ visual dashboards (commonly available in many eQMS tools) that highlight data from KPIs, customer feedback, compliance etc. This data is available for employees to view at the click of a button, at their pace and time, and can be customised for easier comprehension.

Next steps: improving quality management reviews

As regulatory focus shifts toward a holistic quality approach, the role of senior management in establishing effective, customised, and compliant quality systems, is becoming increasingly important.

To fulfil this responsibility effectively, the leadership team must adapt and change its approach in conducting management reviews. Focusing on trends – new technology, data, regulatory, risks, training – is more crucial than just reviewing non-compliances. Leveraging technology to aid in better data collection, tracking, and analysis can lead to more effective management reviews.